Feature Articles

CMOs Seek "the" Competitive Edge

Established Practices Like Lyophilization and Six Sigma Are Finding Novel Uses in Biotech

Productivity

Xcellerex’ FlexFactory® is a bioprocessing manufacturing platform based upon single-use solutions, designed as modules and optimized cleanroom space. The FlexFactory is designed for a specific need, validated, and operated, and then may be transplanted to a new site without issues with proprietary cell lines, media, and technology that may limit a biotech’s future options. Xcellerex operates its own FlexFactory and also sells FlexFactories to clients.

“The automation system used to operate our FlexFactory is a purpose-built, application-specific tool for bioprocess operations, covering both development and manufacturing,” Ken Clapp, senior director of global marketing and product management, explains. “The software integrates the typically separate up- and downstream unit operations and associated equipment into one comprehensive automation environment.”

The result, Clapp says, is a manufacturing facility that can be built and deployed quickly and less expensively than its traditional counterpart. “Integrating automation with disposable manufacturing, with access to contract development and manufacturing services, helps organizations become more productive by aligning manufacturing capacity more closely with regulatory approval,”helping production to start sooner.

Comprehensive Services

Click Image To Enlarge +

Cook Pharmica’s high-speed syringe line under barrier isolator

One of the concerns in outsourcing aspects of development and manufacturing is the risk that inefficiencies will creep into the system and that critical knowledge will not be transferred successfully. Brian Arnold, brand and marketing manager at Cook Pharmica says that working with a CMO that provides comprehensive service at a single location minimizes wasted time, redundancy, information loss, and the number of relationships that must be managed.

European CMO News

RecipharmCobra Bio recently received European patents for its Xer-cise technology, which genetically modifies bacteria without leaving antibiotic resistance genes on their chromosomes. As Rocky Cranenburgh, Ph.D., head of molecular biology and inventor of Xer-cise, explained, “The system uses Xer recombinases, which are native to bacteria.” The Xer-cise cassette consists of an antibiotic resistance gene flanked by dif sites—the recognition sequence for Xer recombinases—and regions homologous to the chromosomal target locus. That cassette is inserted into the target bacterium by homologous recombination.The Xer recombinases resolve the two directly repeated dif sites to a single site, excising the intervening antibiotic resistance gene. “That reduces the steps involved,” Dr. Cranenburgh says, because, “once inserted, you don’t have to transform the bacteria with an additional plasmid carrying a foreign recombinase gene, which subsequently needs to be removed from the cell.”“Xer-cise has enabled molecular biologists at RecipharmCobra and elsewhere to rapidly construct bacterial strains that are not antibiotic resistant, and are therefore advantageous for the commercial production and delivery of biologics,”adds Simon Saxby, vp of biologics.

Richter-Helm BioTec

Richter-Helm BioTec reported that it has modified its bioreactors to use Pichia pastoris. “That technology is very much in demand now,” because of its ability to secrete products and to manufacture complex proteins, such as new antibody formats, said Kai Pohlmeyer, Ph.D., head of business development. The firm also implemented advanced technology to process and manufacture plasmid DNA, which increases yield and maintains highest quality, Dr. Pohlmeyer noted. Last autumn, Richter-Helm added expanded bed adsorption (EBA) chromatography to its technological mix. “With the implementation of EBA chromatography, clients can bypass initial recovery steps because the molecule of interest selectively binds to the EBA material, even from crude broth. We also optimized our E. coli expression systems and feeding strategies for fermentations, increasing yields of 10–20 g/L,” he continued. To further process the increased amounts of raw protein, large-scale chromatography equipment was added.

Boehringer Ingelheim

Boehringer Ingelheim is honing its global strategy, fielding a local team of representatives to be closer to the customer, and making its technologies more widely available to customers through bundling, according to Barbara Esch, Ph.D., marketing communications business intelligence.Those technologies include the development of new expression systems. The E. coli genome integration system, for example, expresses recombinant proteins by integrating the gene of interest into the genome instead of placing the corresponding DNA onto an expression vector, Dr. Esch explained. Therefore, when the E. coli cells divide, each genome retains the gene of interest and expresses it at induction.“We also have downstream technologies,” continued Dr. Esch, and adapted the crystallization purification step long used in chemistry for applications with stable entities, including interferon and some antibody fragments.

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.

Be sure to take the GEN Poll

Climate Change

How would you describe the researchers response to the 2°C global temperature target?

They are right on the mark. A 2°C global temperature rise will push us further over the edge. We have to set a lower target.

A 2°C global temperature rise is a reasonable target on which to focus in order to diminish the impact of climate change.

We have already gone beyond the threshold for getting a handle on climate change. So now we just need to learn how to adapt to the inexorable climatic changes with which we will have to deal going forward.

They are right on the mark. A 2°C global temperature rise will push us further over the edge. We have to set a lower target.

38.9%

A 2°C global temperature rise is a reasonable target on which to focus in order to diminish the impact of climate change.

22.2%

We have already gone beyond the threshold for getting a handle on climate change. So now we just need to learn how to adapt to the inexorable climatic changes with which we will have to deal going forward.

If you have any questions about your subscription, click
hereto email us or call at (914) 740-2189.

You may also be interested in subscribing to the GEN magazine, an indispensable
resource for everyone involved in the business of translating discoveries at the
bench into solutions that fight disease and improve health, agriculture, and the
environment. Subscribe
today to see why over 60,000 biotech professionals read GEN to
keep current in the areas of genomics, proteomics, drug discovery, biomarker discovery,
bioprocessing, molecular diagnostics, collaborations, biotech business trends, and
more.